Trial Results of Mesoblast Cell Therapy in End-Stage Heart Failure Selected as Late-Breaking Presentation at 2018 American He...
October 02 2018 - 6:00AM
Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced that the
159-patient randomized placebo-controlled Phase 2b trial
evaluating its allogeneic mesenchymal precursor cell (MPC) product
candidate MPC-150-IM in the treatment of end-stage heart failure
patients implanted with a left ventricular assist device (LVAD) has
been selected as a late-breaking presentation at the 2018
Scientific Sessions of the American Heart Association
being held in Chicago from November 11-13.
The presentation is entitled ‘Intramyocardial
Injection of Mesenchymal Precursor Cells in Left Ventricular Assist
Device Recipients: Impact on Myocardial Recovery and
Morbidity’, and will be delivered in a late-breaking Clinical
Science session on November 11.
The trial’s independent investigators will present end of
study safety and efficacy results, and an independent
discussant will provide additional comments and
conclusions. This Phase 2b trial is being funded
by the United States National Institutes of Health (NIH) and
the Canadian Institutes for Health Research, and conducted by
the NIH-funded Cardiothoracic Surgical Trials Network (CTSN).
The United States Food and Drug Administration (FDA) has granted
Mesoblast a Regenerative Medicine Advanced Therapy (RMAT)
designation for use of MPC-150-IM in this patient population based
on results from an earlier NIH-funded 30-patient Phase
2 trial that demonstrated improved heart function, prolonged
time to re-hospitalization and improved early survival after a
single intra-myocardial injection of Mesoblast’s MPCs at the time
of an LVAD implant.
About Mesoblast Mesoblast Limited
(ASX: MSB; Nasdaq: MESO) is a world leader in developing allogeneic
(off-the-shelf) cellular medicines. The Company has leveraged its
proprietary technology platform to establish a broad portfolio of
late-stage product candidates with three product candidates in
Phase 3 trials – acute graft versus host disease, chronic heart
failure and chronic low back pain due to degenerative disc disease.
Through a proprietary process, Mesoblast selects rare mesenchymal
lineage precursor and stem cells from the bone marrow of healthy
adults and creates master cell banks, which can be industrially
expanded to produce thousands of doses from each donor that meet
stringent release criteria, have lot to lot consistency, and can be
used off-the-shelf without the need for tissue matching. Mesoblast
has facilities in Melbourne, New York, Singapore and Texas and is
listed on the Australian Securities Exchange (MSB) and on the
Nasdaq (MESO). www.mesoblast.com
Forward-Looking StatementsThis announcement
includes forward-looking statements that relate to future events or
our future clinical development and financial performance and
involve known and unknown risks, uncertainties and other factors
that may cause our actual results, levels of activity, performance
or achievements to differ materially from any future results,
levels of activity, performance or achievements expressed or
implied by these forward -looking statements. We make such
forward-looking statements pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995 and other
federal securities laws. Forward- looking statements should not be
read as a guarantee of future performance or results, and actual
results may differ from the results anticipated in these
forward-looking statements, and the differences may be material and
adverse. Forward-looking statements include, but are not limited
to, statements about the timing, progress and results of
Mesoblast’s preclinical and clinical studies; Mesoblast’s ability
to advance product candidates into, enroll and successfully
complete, clinical studies; the timing or likelihood of regulatory
filings and approvals; and the pricing and reimbursement of
Mesoblast’s product candidates, if approved. You should read this
press release together with our risk factors, in our most recently
filed reports with the SEC or on our website. Uncertainties and
risks that may cause Mesoblast’s actual results, performance or
achievements to be materially different from those which may be
expressed or implied by such statements, and accordingly, you
should not place undue reliance on these forward-looking
statements. We do not undertake any obligations to publicly update
or revise any forward-looking statements, whether as a result of
new information, future developments or otherwise.
For further information, please contact:
Julie Meldrum Corporate Communications T: +61 3 9639 6036 E:
julie.meldrum@mesoblast.com
Schond GreenwayInvestor RelationsT: +1 212 880 2060E:
schond.greenway@mesoblast.com
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